ISO 15223-1:2016 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | 5.1.1 | Manufacturer | Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC |
 | 5.1.2 | Authorized Representative in the European Community | Indicates the authorized representative in the European Community. |
 | 5.1.3 | Date of Manufacture | Indicates the date when the medical device was manufactured |
 | 5.1.4 | Use-by date | Indicates the date after which the medical device is not be used. |
 | 5.1.5 | Batch Number | Indicates the manufacturer’s batch code so that the batch or lot can be identified. |
 | 5.1.6 | Catalog Number | Indicates the manufacturer’s catalogue number so that the medical device can be identified |
 | 5.1.8 | Importer | Indicates the name and address of importing entity |
 | 5.2.1 | Sterile | Indicates a medical device that has been subjected to a sterilization process |
 | 5.2.4 | Sterilized using irradiation | Indicates a medical device that has been sterilized using irradiation. |
 | 5.2.6 | Do Not Re-sterilize | Indicates a medical device that is not to be re-sterilized. |
 | 5.2.7 | Non-Sterile | Indicates a medical device that has not been subjected to a sterilization process |
 | 5.2.8 | Do not use if package is damaged | Indicates a medical device that should not be used if the package has been damaged or opened. |
 | 5.2.11 | Single Sterile Barrier System | Indicates a single sterile barrier system |
 | 5.2.12 | Double Sterile Barrier System | Indicates two sterile barrier systems |
 | 5.3.2 | Keep away from sunlight | Indications a medical device that needs protection from light sources. |
 | 5.3.4 | Keep Dry | Indicates a medical device needs to be protected from moisture. |
 | 5.3.7 | Temperature limit | Indicates the temperature limits to which the medical device can be safely exposed. |
 | 5.4.2 | Do not re-use | Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. |
 | 5.4.3 | Consult instructions for use | Indicates the need for the user to consult the instructions for use |
 | 5.4.4 | Caution | Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. |
 | 5.4.5 and Annex B.2 and Guidance for Industry and US Food and Drug Administration Staff | Not made with natural rubber latex | Indicates that neither the medical device nor the packaging of the medical device contains the presence of natural rubber latex |
 | 5.7.7 | Medical Device | Indicates the item is a medical device |
European Medical Device Directive 93/42/EEC / European Medical Device Regulation 2017/745
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | Article 17 | CE Conformity Marking and Notified Body Number | Product conforms to the applicable requirements for a medical device as set forth in the regulation and assessed by the certifying notified body. |
 | Article 17 | CE Conformity Marking | Product conforms to the applicable requirements for medical device as set forth in the regulation and assessed by the certifying notified body |
United States’ Title 21 of the Code of Federal Regulations (CFR) Section 801.109(b)(1)
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | 21 CFR Section 801.109 (b) (1) and United States Food and Drug Administration Guidance for Industry – Alternative to Certain Prescription Device Labeling Requirements, Issued on January 21, 2000 | Prescription Use Only | CAUTION: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner |
Union of Orthodox Jewish Congregations of America (the “Orthodox Union”) certification requirements for kosher products
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | Kosher Requirements per Union of Orthodox Jewish Congregations of America | Certified Kosher | Certified Kosher per the Union of Orthodox Jewish Congregations of America as Pareve (contains neither milk or meat ingredients) |
Other Symbols
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | NA | Made in the USA | All or virtually all significant parts and processing of this product are of U.S. origin. |
Therapeutic Goods Medical Device Regulation
| Symbol | Reference | Title | Description |
|---|---|---|---|
 | NA | Australian Sponsor | Indicates the authorized sponsor in the Australian market. |
Last Updated 2/1/2022
